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Lithium batteries and Medical Devices in the EU

The safety of battery operated devices is attracting increasingly stringent scrutiny and it has been determined that, as from 1 May 2012, all lithium-ion batteries must be tested and certified to the standard IEC 62133. The exceptions are for information technology equipment (standard IEC 60950-1 applies) and audio/video devices where IEC 60065 applies.

This includes all batteries and battery packs intended for use in conjunction with medical products which must be evaluated and certified accordingly. (This would normally be undertaken and certified by the battery manufacturer / supplier.)

A supplier’s pre-certification to IEC 62133 will assist to assure that the legally required and applicable Medical Device Directive essential requirements may be answered , in particular essential requirement 9.3:

9.3 Devices must be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to substances which could cause combustion.

This will then relate to the way the a medical device manufacturer may demonstrate that hazards from using such batteries in their device(s) have been risk assessed to the EU harmonised and essential standard EN ISO 14771; 2012. By undertaking such a risk study, as part of the Technical File, it should be demonstrated that the device is:

  1. Inherent safety by design
  2. Protective measures in the actual medical device and/or manufacturing process
  3. Information for safety, such as labeling and instructions for use

If the battery is incorporated within a device then the whole device, including the actual battery and charging circuits, should conform to EN ISO 60601-1 which covers basic safety and essential performance for all Medical Electrical Equipment.

With the spread of wireless and mobile technology, electromagnetic disturbances arise which can affect medical equipment and prevent it from working in the way it was intended to. Therefore it is also essential that such medical equipment is not oversensitive to radio frequency interference and in addition electromagnetic emissions from it should not interfere with other equipment and systems. Essentially this means testing and certifying to

BS EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

Before any electrically powered device will be accepted in a clinical or hospitals environment it would be expect it to be certified accordingly before they would purchase.

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